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LNEBIO101L2

Glucose, Creatinine, Glycerides, Cholesterol, in human frozen serum

LNE Certified Reference Material, commutable, JCTLM listed

form

liquid

quality

commutable, JCTLM listed

shelf life

limited shelf life, expiry date on the label

composition

human serum, >99.7%

IVD

not for in vitro diagnostic use

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General description

LNE CRM Bio 101L2 is a higher-order certified reference material produced by the French metrological institute LNE in compliance with ISO 17034 requirements. This secondary standard is intended for use as quality control material to assess the measurement bias or measurement uncertainty of established or new measurement procedures for the determination of creatinine, glucose, total cholesterol, total glycerides, HDL-cholesterol and LDL-cholesterol in human serum.
The Certified Reference Materials LNE CRM Bio 101L1 and LNE CRM Bio 101L2 correspond to 2 pools of Human Frozen Serum that were prepared according to the Clinical Laboratory Standards Institute (CLSI) C37-A guidelines describing the preparation and validation of commutable frozen human serum pools as Secondary Reference Materials for Cholesterol Measurement. Samples commutability was assessed through 2 commutability studies according to the difference in bias approach described in the IFCC recommendations on commutability assessment involving several clinical laboratories. Commutability results are reported in the certificate of analysis.

Storage Class Code

10 - Combustible liquids

WGK

WGK 3

Regulatory Information

动植物来源生物产品
高风险级别生物产品--人源产品

Certificate of Analysis

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Certificate of Origin

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